Deployment of Functional Optical Brain Monitor [fNIR] in Clinical Anesthesia

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Drexel University

Status

Completed

Conditions

Surgical Procedures, Operative

Treatments

Device: fNIR light emitting and sensing device

Study type

Interventional

Funder types

Other

Identifiers

NCT00448877
16618

Details and patient eligibility

About

The purpose of this study is to determine whether or not a new brain function monitor can distinguish between anesthetized and awake patients. The device implemented utilizes functional near-infrared (fNIR) technology to detect anesthesia depth as well as reaction to stimuli during surgical procedure. After obtaining consent the device is placed across the forehead of the patient. A baseline signal is obtained prior to induction. The fNIR signal is continuously recorded throughout the procedure. Key events as well as administration of drug are recorded in order to observe changes in the signal trend. Neither the device nor the light emitted is hazardous to the patient - no risks or discomforts are involved.

Enrollment

50 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All patients who will have surgery
  • 18-80 years old
  • No restrictions on gender, race, or religion

Exclusion criteria

  • Head and face surgery
  • Induced hypotension
  • Profound anemia
  • Scar/tattoo on forehead
  • Prior history of frontal lobe surgery
  • Hemoglobinopathies
  • Patients not undergoing general anesthesia
  • Surgeries in the prone position
  • Allergy to adhesive tape

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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